Key Dates

Related Announcements

• February 24, 2005 - RESCINDED - Guidance on Prompt Reporting to OLAW Under the PHS Policy on Humane Care and Use of Laboratory Animals. See Notice NOT-OD-05-034.

Issued by

Office of The Director, National Institutes of Health (OD)

Purpose

This Notice provides updates to guidance that was published in NOT-OD-05-034 Guidance on Prompt Reporting to OLAW Under the PHS Policy on Humane Care and Use of Laboratory Animals (February 24, 2005).

Updates to Guidance

The 21st Century Cures Act directed the National Institutes of Health (NIH), in collaboration with the United States Department of Agriculture (USDA) and the Food and Drug Administration (FDA), to conduct a review of applicable regulations and policies for the care and use of laboratory animals and to make revisions, as appropriate, to reduce the administrative burden on investigators while maintaining the integrity and credibility of research findings and protection of research animals. Accordingly, the NIH Office of Laboratory Animal Welfare (OLAW) has reviewed the guidance in NIH Guide Notice NOT-OD-05-034 to refine and update examples of reportable situations, examples of situations where reporting is not normally required, the time frame for reporting, and the information to be reported.

After a comprehensive review, OLAW has determined that guidance on reporting requirements in NIH Guide Notice NOT-OD-05-034 (rescinded with issuance of this Notice) is still applicable and incorporated in this Notice. In addition to general edits to improve clarity, six substantive content revisions were made:

1. Clarification on how reporting requirements apply based on the scope of the institution’s Animal Welfare Assurance. This can be found in the sentence underneath the first paragraph in the section discussing examples of reportable situations.
2. Clarification on situations that may impact activities subject to the PHS Policy on Humane Care and Use of Laboratory Animals (PHS Policy). This is the final bullet in the section discussing examples of situations where reporting is required.
3. Addition of examples to the list of situations that normally are not required to be reported to OLAW. These are the final three bulleted items in the section on examples of situations where reporting is not normally required.
4. Updates to the guidance for inclusion of award numbers and funding sources in reports to OLAW. These updates can be found in the second and third bullets in the section regarding information to be reported.
5. Clarification on how reporting requirements apply when federal entities have a memorandum of understanding (MOU) with OLAW that applies the PHS Policy to activities they conduct or fund involving live, vertebrate animals used or intended for use in research, research training, experimentation, or biological testing or for related purposes (PHS Policy section III). This is introduced in the background and is clarified in the section on information to be reported.
6. Clarification that the signature of the Institutional Official (IO) on the final report to OLAW provides verification of compliance with PHS Policy section IV.F.3. This can be found in the section on information to be reported.

The revised guidance on reporting noncompliance may be found below.

Background

The Office of Laboratory Animal Welfare (OLAW) oversees animal activities of Assured institutions by the authority of the Health Research Extension Act of 1985 (HREA) and the PHS Policy. Through memoranda of understanding (MOUs), OLAW also has oversight authority for animal activities supported or conducted by other federal agencies. For the current list of agencies having an MOU with NIH for oversight of animal activities, see the OLAW website. For the purposes of this Notice, “PHS-supported activities” include PHS-funded or supported activities as well as activities subject to the PHS Policy, such as federal funding entities that have an MOU for technical and administrative services with OLAW.

The PHS Policy, section IV.F.3., requires that:

The Institutional Animal Care and Use Committee (IACUC),“through the Institutional Official, shall promptly provide OLAW with a full explanation of the circumstances and actions taken with respect to:

a. Any serious or continuing noncompliance with this Policy;

b. Any serious deviation from the provisions of the Guide [for the Care and Use of Laboratory Animals]; or

c. Any suspension of an activity by the IACUC.”

IACUC suspensions of activities are cited in section IV.C.6. and 7. of the PHS Policy and require a convened meeting of a quorum of the IACUC and the vote of a majority of the quorum present. The IO must review the reasons for suspension in consultation with the IACUC, take appropriate corrective action and report that action with full explanation to OLAW.

All institutions with an Animal Welfare Assurance (Assurance) are required to comply with the provisions of section IV.F.3. The IO signing the Assurance, in concert with the IACUC, is responsible for this reporting. Reporting promptly to OLAW under section IV.F.3. serves dual purposes. Foremost, it ensures that institutions deliberately address and correct situations that affect animal welfare and compliance with the PHS Policy. In addition, it enables OLAW to monitor the institution's animal care and use program oversight under the PHS Policy, evaluate allegations of noncompliance, and assess the effectiveness of PHS policies and procedures.

The underlying foundation of the PHS Policy is one of institutional self-evaluation, self-monitoring, and self-reporting. The Health Research Extension Act of 1985 requires that institutions be provided a reasonable opportunity to take corrective action before a grant or contract is suspended or terminated, and it is OLAW's role to assess whether the corrective actions reported by institutions under PHS Policy section IV.F.3. are adequate. OLAW will assist the reporting institution in developing definitive corrective plans and schedules if necessary. Compliance actions affecting an award are rare because institutions are usually able to address incidents successfully and take appropriate actions to prevent reoccurrence.

Examples of Reportable Situations

As a comprehensive list of definitive examples of reportable situations is impractical, the examples below do not cover all instances but demonstrate the threshold at which OLAW expects to receive a report. Items not listed may still qualify for reporting. Institutions should use rational judgment in determining what situations meet the provisions of PHS Policy section IV.F.3. and fall within the scope of the examples below and consult with OLAW if in doubt. OLAW welcomes inquiries and discussion and will provide guidance regarding specific situations.

Note that if the institution’s Assurance states that incidents will be reported regardless of funding source, the incident must be reported.

• Conditions that jeopardize the health or well-being of animals (including natural disasters, accidents, and mechanical failures) resulting in actual harm or death to animals
• Conduct of animal-related activities without appropriate IACUC review and approval
• Failure to adhere to IACUC-approved protocols
• Implementation of any significant change to IACUC-approved protocols without prior IACUC approval as required by section IV.B.7.
• Conduct of animal-related activities beyond the expiration date established by the IACUC (note that a complete review under section IV.C. is required at least once every three years)
• Conduct of official IACUC business requiring a quorum (full Committee review of an activity in accord with section IV.C.2. or suspension in accord with section IV.C.6.) in the absence of a quorum
• Conduct of official IACUC business during a period of time that the Committee is improperly constituted
• Failure to correct deficiencies identified during the semiannual evaluation in a timely manner
• Chronic failure to provide space for animals in accordance with recommendations of the Guide unless the IACUC has approved a protocol-specific deviation based on scientific justification, or a performance standard (Guide, p.56)
• Participation in animal-related activities by individuals who have not been determined by the IACUC to be appropriately qualified and trained as required by section IV.C.1.f.
• Failure to monitor animals post-procedurally as necessary to ensure well-being (e.g., during recovery from anesthesia or during recuperation from invasive or debilitating procedures)
• Failure to maintain appropriate animal-related records (e.g., identification, medical, husbandry)
• Failure to ensure death of animals after euthanasia procedures, e.g., failed euthanasia with carbon dioxide (CO₂)
• Failure of animal care and use personnel to carry out veterinary orders (e.g., treatments)
• IACUC suspension or other institutional intervention that results in the temporary or permanent interruption of an activity due to noncompliance with the PHS Policy, Animal Welfare Act, the Guide, or the institution's Assurance
• Any situation in a functional, programmatic, or physical area that could affect activities subject to the PHS Policy, regardless of funding source (e.g., inadequate sanitation due to malfunctioning cage washer, room temperature extremes due to HVAC failures, etc.)

Situations that meet the provisions of section IV.F.3. and are identified by external entities such as the United States Department of Agriculture or AAALAC International, or by individuals outside the IACUC or outside the institution, are not exempt from reporting.

Examples of Situations Where Reporting is Not Normally Required

OLAW recognizes that there may be levels of illness and death in virtually any animal-related activity. Accordingly, there may be levels of morbidity and mortality associated with the care and use of animals in research, research training, experimentation, or biological testing or for related purposes that are not the result of violations of the PHS Policy or serious deviation from provisions of the Guide. The examples below typically do not meet the threshold for reporting; however, the IACUC is to consider the specific circumstances, intent, and actual effect to animal welfare before electing not to report.

• Death of animals that have reached the end of their natural life spans
• Death or failures of neonates to thrive when husbandry and veterinary medical oversight of dams and litters was appropriate
• Animal death or illness from spontaneous disease when appropriate quarantine, preventive medical, surveillance, diagnostic, and therapeutic procedures were in place and followed
• Animal death or injuries related to manipulations that fall within parameters described in the IACUC-approved protocol (however, unexpected outcomes such as increased morbidity or mortality may still require reporting, depending on the specific circumstances)
• Infrequent incidents of drowning or near-drowning of rodents in cages when it is determined that the cause was water valves jammed with bedding (frequent problems of this nature, however, must be reported promptly along with corrective plans and schedules)
• Animal injury by conspecifics during social housing when proper introduction and subsequent monitoring occurred

Some circumstances, though they may represent a deviation from expected standards, may not rise to the level of reporting when no welfare issues are identified. For example:

• Expired medications identified after the expiration date, but not administered to animals after expiration
• Moderate fluctuations in temperature and humidity, when brief and infrequent, where no animal health or welfare issues resulted, and when a program of required daily monitoring was in place

Time Frame for Reporting

Institutions should notify OLAW of matters falling under PHS Policy section IV.F.3. promptly, i.e., without delay. Since section IV.F.3. requires a full explanation of circumstances and actions taken, and the time required to fully investigate and devise corrective actions may be lengthy, OLAW recommends that an authorized institutional representative provide a preliminary report to OLAW as soon as possible and follow up with a thorough report once action has been taken. Reports should be submitted as situations occur and not collected and submitted in groups or with the Annual Report to OLAW.

Information to be Reported

The essential information below allows OLAW to assess the circumstances and actions taken to correct and prevent reoccurrence of the situation. Include as many of the following items as possible in the preliminary report to OLAW:

• Assurance number
• Award numbers for National Science Foundation (NSF) funded activities. Only NSF award numbers must be included in the report. Other award numbers need not be included unless requested by OLAW or if determined to be applicable by the reporting institution.
• Funding source for all PHS supported activities, including those having an MOU with OLAW.  E.g., NIH, NSF, National Aeronautics and Space Administration (NASA), U.S. Department of Veterans Affairs (VA)
• Complete explanation of the situation, including:
  • What happened;
  • When and where;
  • Species of animal(s) involved; and
  • Category of individual(s) involved (e.g., Principal Investigator or Co-Principal Investigator, technician, animal caretaker, student, veterinarian, etc.)
• A full description of any situation, that in the judgment of the IACUC and Institutional Official, may be a threat to  PHS-supported activities
• Description of actions taken by the institution to address the situation
• Description of short- or long-term corrective plans and implementation schedule(s)

The final report should identify the date of the preliminary report, address any of the above not included in the preliminary report, and provide any updates or changes since the preliminary report, if made. In accordance with the PHS Policy, section IV.F.3., final reports are to be submitted by the IACUC through the IO. The signature of the IO provides verification that this requirement is met.

Preliminary and final reports should be made to OLAW’s Division of Compliance Oversight.

Additional details and resources may be found on the OLAW website.

Inquiries

Please direct all inquiries to:

Office of Laboratory Animal Welfare (OLAW)
Telephone: 301-496-7163
Email:[email protected]